$10 Billion Multiple Sclerosis Market Competes For EU Drug Approvals

Written by Sy Kraft on January 21, 2011

The multiple sclerosis market is estimated to be worth $10 billion and globally 2.5 million people are affected. However the competitive solutions landscape shrank today as a drug in pill form may be available for the first time to one of over half a million residents of the European Union who suffer from multiple sclerosis, already being sold in the U.S. and Russia . Swiss-based pharmaceutical company Novartis, which manufactures the drug, said a license allowing Gilenya to be marketed in the UK was expected in the next few months.

Around 100,000 persons suffer from MS in the UK and half a million in all of Europe. MS is the result of damage to myelin – a protective sheath surrounding nerve fibers of the central nervous system. When myelin is damaged, this interferes with messages between the brain and other parts of the body. For some people, MS is characterized by periods of relapse and remission while for others it has a progressive pattern. For everyone, it makes life unpredictable.

“The first available oral multiple-sclerosis treatment that offers significant efficacy for appropriate patients is a welcome alternative.”

This news comes as a major blow to competing pharma companies seeking regulatory approvals for similar solutions. This introductory approval comes in the wake of a similar drug, Cladribine, being killed by European Medicines Agency’s Committee for Medicinal Products for Human Use last Friday. Also, Biogen Idec Inc. said the same European panel recommended against approval of Biogen’s multiple-sclerosis pill Fampyra, questioning the effectiveness of the drug that aims to improve walking in MS patients. That drug’s developer is Acorda Therapeutics Inc.

Teva and Sanofi-Aventis SA currently own the market’s best-selling drug Copaxone, which had more than $2.8 billion in sales in 2009. Biogen’s Avonex also had more than $2 billion in annual revenue, while Bayer’s Betaseron and Merck’s Rebif had more than $1 billion in sales.

While many existing drugs need to be administered through a daily injection or infusion, the medicines can cause side effects such as flu-like symptoms. The orally taken drug Gilenya to be used in Europe will be prescribed at a 0.5-milligram daily dose to treat patients with highly active relapsing-remitting multiple sclerosis.

Because of the simplicity of administration, it is estimated Gilenya could reach up to $3.5 billion in annual peak sales and help the Swiss company cushion the impact from patent expiries of heart drug Diovan and cancer medicine Glivec. Diovan, which reached sales of more than $6 billion in 2009, is set to lose patent protection in Europe later this year, with analysts expecting sales losses of about $1 billion due to generic competition in 2011.